New Drug Application of Penpulimab Co-developed by Sino Biopharmaceutical and Akeso Accepted by the National Medical Products Administration

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Sino Biopharmaceutical Limited (HKEX: 1177), a leading, innovative R&D driven pharmaceutical conglomerate in the PRC, has announced that the new drug application of the anti PD-1 monoclonal antibody drug (generic name: Penpulimab; R&D code: AK105) jointly developed and commercialized with Akeso, Inc. (HKEX: 9926), a biopharmaceutical company committed to R&D, production and commercialization of affordable innovative antibody drugs for patients worldwide, has been accepted by the National Medical Products Administration of the PRC, for the treatment of patients with relapsed or refractory Classical Hodgkin’s Lymphoma.

Classical Hodgkin Lymphoma (cHL) is a B-cell lymphoma, and is also one of the most common malignancies among young people. It has a single modal age distribution in China with a peak at around 40 years of age . cHL is one of the few tumors that can be cured, and the most common therapy is chemotherapy plus radiotherapy, with the 5-year survival rate of patients as high as over 80%. Although the first-line chemotherapy has a high clinical cure rate, a considerable portion of patients are insensitive to chemotherapy and approximately 5% to 10% of patients do not respond to the initial treatment .

Professor Zhu Jun, Co-principal investigator of the lead unit Beijing Cancer Hospital is full of expectations for such a differentiated anti PD-1 monoclonal product and said, through bioengineering technology, Penpulimab completely eliminate the binding activity of Fc receptors and avoid the antibody-dependent cell-mediated cytotoxicity (ADCC) effect. At the same time, compared with other drugs available in the market working on the same target, it has a slower rate of antigen binding and dissociation, which makes the biological effect stronger and improves its anti-tumor activity.

Co-lead researcher Professor Song Yuqin, Director of Lymphoma Department at Peking University Cancer Hospital said, in clinical trial, Penpulimab was observed with gratifying therapeutic data and good safety. As a clinician, Professor Song hoped that Penpulimab can be launched to the market soon, which will benefit more patients and their families.

About Sino Biopharmaceutical Limited (HKEX: 1177)
Sino Biopharmaceutical Limited is a leading, innovative R&D driven pharmaceutical conglomerate in the PRC. Its business encompasses a fully-integrated chain which covers an array of R&D platforms, a line-up of intelligent production and a strong sales system. The Group’s products have gained a competitive foothold in various therapeutic categories with promising potentials, comprising a variety of biopharmaceutical and chemical medicines for treating tumors, liver diseases, respiratory system diseases, anti-infectious diseases and orthopedic diseases.

Sino Biopharm is a constituent stock of the following indices: MSCI Global Standard Indices – MSCI China Index, Hang Seng Index, Hang Seng Index – Commerce & Industry, Hang Seng Composite Index, Hang Seng Composite Industry Index – Consumer Goods, Hang Seng Composite LargeCap Index, Hang Seng Composite LargeCap & MidCap Index, Hang Seng China (Hong Kong-listed) 100 Index and Hang Seng Stock Connect Hong Kong Index. Sino Biopharm was ranked as one of “Asia’s Fab 50 Companies” by Forbes Asia for three consecutive years in 2016, 2017 and 2018. http://www.sinobiopharm.com/.

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